INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use

Systemic Lupus Erythematosus (SLE) Clinical Trial

— INTERSTELLAR  

Official title:

INTERSTELLAR - Multi-National, Observational, Prospective, Post-Launch, Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06314282
• Other study ID #: D3461R00072
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: August 31, 2027

Study information

• Verified date: February 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

INTERSTELLAR study will generate critical prospective real-world evidence on the benefits of adding Anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients. The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations. The study will use standardized objectives, inclusion/exclusion criteria and outcome measures across all countries participating in this study including GCC (Qatar, KSA), Mexico, CAMCAR (Costa Rica, Panama, Dominican Republic), Colombia, Argentina, Taiwan, and Egypt, and any other countries that may be included in the study, in order to facilitate a comparison and analysis across all countries included in this study.

Description:

INTERSTELLAR is a multi-country, single-arm, observational, cohort study, with 1 year retrospective baseline data and 1 year of prospective follow-up. The study will be initiated on a country-by-country basis following the commercial launch of anifrolumab. The enrolment period is anticipated to be 12 months per country. In general, patients will enter the study between the first anifrolumab prescription and infusion (index), with follow-up until death, loss to follow-up, patient discontinuing the study, or end of study period (whichever occurs first). Relevant clinical and patient reported outcome (PRO) data collection for the entire follow up will continue for patients who have discontinued anifrolumab during the study, unless the patients have withdrawn their consent for participation in the study

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged 18 years or older at study enrolment.

2. Fulfilled the 2019 EULAR/ACR criteria1 for SLE at the time of study entry.

3. Prescribed anifrolumab for their SLE treatment for the first time, according to approved country-specific label.

4. It is important to note that a physician decision to prescribe anifrolumab will need to occur prior to any study-related discussion.

5. In countries where prescription reimbursements are authorized on a case-by-case basis, authorization (ie, patient access to treatment) will be required for study entry.

6. Provided informed consent to participate in the study.

7. Willing and able to participate in all required study evaluations and procedures.

Exclusion Criteria:

1. Currently participating in an anifrolumab early access/compassionate use program or an interventional clinical trial with an investigational product.

2. Previous exposure to anifrolumab as part of a clinical trial or early access program.

3. Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil [MMF]/cyclophosphamide [CYC] + high dose steroids), isolated Class V lupus nephritis, or active severe or unstable neuropsychiatric lupus.

4. Any other condition which the investigator deems to limit a patient's ability to understand the informed consent or complete the PROs.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus (SLE)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PGA	Physician's overall assessment of disease activity on a visual analog scale ranging from 0 (no activity) to 3 (severe activity).	Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12
Primary	SLEDAI-2K	24 lupus-related (weighted) items to assess disease activity, rated as 'present' or 'absent' and attributed to active lupus. Scored on a scale from 0 to 105, with 0 being inactive disease.	Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12
Primary	CLASI	Skin activity and damage assessment completed by physician by scoring each specific area as indicated on the form. The higher the score, the worse the activity/damage.	Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12
Primary	FACIT-Fatigue	A 13-item questionnaire to assess the impact of fatigue on a 5-point verbal rating scale. Scores range from 0 to 52; a higher score indicates les fatigue	Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12
Primary	LupusQoL	A 34-item questionnaire on a verbal rating scale covering several domains, including daily activities, pain, fatigue and sleep in relation to lupus symptoms.	Baseline (pre-infusion) Month 3, Month 6, Month 12
Primary	EQ-5D-5L	5-item questionnaire measuring 5 dimensions of general health status on a verbal rating, and a single visual analog scale about overall perceived health today	Baseline (pre-infusion) Month 3, Month 6, Month 12